Accidental FallsNCT02696668
Advances in Group-based Falls Rehabilitation
A study testing modified FaME and Multisensory in people with Accidental Falls, run by King's College London.
Trial summary
This study's main aim is to compare the effect of a modified FaME vs. a multisensory balance exercise programme on falls risk, balance confidence and quality of life in older adults who fall or at risk of falling when implemented in a group setting. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- modified FaME and Multisensory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older adult 65 years old or older who have either experienced a fall or are at risk of falling (Timed Up and Go score >15 seconds) and have been referred by the assessing physiotherapist to a falls rehabilitation group class.
Who cannot join
- Older adults who have:
- Cardiac syncope/pre-syncope ii) Postural hypotension iii) A Mini Mental State score of <24/30. ii) Diagnosis of dementia or mild cognitive impairment ii) Acute illness iii) Side effects of medication or drug intoxication iv) Evident musculo-skeletal or neurological deficit that is likely to contribute to postural instability
- Any individual with poor written/spoken English will not be included in the study due to the need to complete multiple questionnaires.
- Individuals with a known history of epilepsy in the last one year or currently experiencing migraine will not be included in this study due to the use of optokinetic stimuli.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of a Modified FaME vs. a Multisensory Group Balance Programme on Falls Risk, Balance Confidence and Quality of Life in Older Adult Who Fall or Are at Risk of Falling
This study's main aim is to compare the effect of a modified FaME vs. a multisensory balance exercise programme on falls risk, balance confidence and quality of life in older adults who fall or at risk of falling when implemented in a group setting.
Read the detailed description
Falls in older adults have a major impact on health, morbidity and mortality and have significant cost implications to healthcare providers (Alexander et al., 1992, Tinetti and Williams, 1998, Davis et al., 2010). Government legislation states targeted multifactorial falls rehabilitation programmes should be provided to older adult fallers (Excellence, 2013). The FaME programme, a group based rehabilitation programme is reported effective for improving balance and walking speed, and reducing the number of falls, chance of hospitalization, institutionalization, and death, and fear of falling (Skelton et al., 2005, Yeung et al., 2014). Sensory integration and re-weighting of peripheral sensory information from visual, somatosensory, and vestibular (i.e. inner ear) systems play an important role in maintaining balance (Horak, 2006). However, until recently no studies had incorporated vestibular exercises into falls rehabilitation programmes and therefore, the efficacy of this type of multisensory balance programme in older adult fallers was unknown.
A recent study showed that a programme combining the widely used modified OTAGO falls rehabilitation programme with multisensory balance exercises was feasible in older adult fallers and may have a greater beneficial effect on balance, gait, and falls risk compared to the OTAGO programme in isolation (Liston et al., 2014). However, multisensory rehabilitation targeting sensory integration and re-weighting which is crucial for postural control is not addressed in current guidelines. To develop the best programme for fall prevention, understanding the complexity of postural control and defining a specified exercise programme targeting essential systems is required. The FaME programme includes certain multisensory balance exercises, but these are introduced only in the latter phase of the programme. This study's main aim is to compare the effect of a modified FaME vs. a multisensory balance exercise programme on falls risk, balance confidence and quality of life in older adults who fall or at risk of falling when implemented in a group setting.
Research questions:
Primary research question:
Does exposure to multisensory balance rehabilitation provide better outcome in balance confidence, falls risk and quality of life in older adult who fall or are at risk of falling compared to the modified FaME programme?
Secondary research questions:
- What is the long term effect of a multisensory balance rehabilitation programme vs. the modified FaME on all outcome measure scores and falls rate?
- Is there a relationship between baseline cognitive function, vestibular function and intervention outcome?
- Can vestibular dysfunction be effectively screened for in a community setting?
Study design:
This study will be a single blinded randomised control study to investigate the effect of the multisensory balance rehabilitation programme vs. the modified FaME on falls risk, balance confidence and quality of life in older adults who fall or are at risk of falling. This study will have two arms provided within a community-based setting. This study will compare intervention outcome between participants receiving the modified FaME falls rehabilitation programme and those receiving multisensory balance rehabilitation exercises.
- Conditions
- Accidental Falls
- Being tested
- modified FaME, Multisensory
- Keywords
- multisensory exercises, group-based balance exercise programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified FaMEOther
Group based exercise classes one hour weekly for 16 weeks. Each exercise class will have 8-10 participants and two instructors. The components of the FaME programme include specific falls management strategies, such as bone loading, gait, dynamic posture, balance, reaction and co-ordination training, functional floor activities to improve coping skills and confidence.
MultisensoryOther
Group based exercise classes one hour weekly for 16 weeks. Each exercise class will have 8-10 participants and two instructors.Participants will receive an initial assessment by the research physiotherapists to determine the most appropriate interventions for each participant. Interventions used will include:
- Limits of stability training with eyes open / eyes closed
- Self induced movement strategies with eyes open / eyes closed
- Gaze stability exercises in sitting / standing / walking
- Sensory integration
- Habituation exercises
| Study group | Role | What they receive |
|---|---|---|
| modified FaME | Active comparator | Participants in the modified FaME group will receive a 16 weeks falls rehabilitation programme which will be tailored and progressed according to their abilities and their needs by the physiotherapist / instructor providing the rehabilitation at the hospital. Receives: Other: modified FaME |
| Multisensory | Experimental | Participants in the multisensory group will receive balance exercises training which will be tailored and progressed to their abilities and needs. Receives: Other: Multisensory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Gait Assessment
A 10-item test assesses complex gait tasks such as walking with head turns or stepping over an obstacle
Measured: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
Secondary outcomes (8)
Timed Up and Go test
A validated test of balance used to examine functional mobility.
Measured: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
Mini Balance Evaluation Systems Test
A validated test designed to assess multiple aspects of postural control systems that may contribute to poor functional balance in adults
Measured: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
Activities-Specific Balance Confidence Scale
A validated self-report scale to assess balance confidence in daily activities
Measured: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
Falls Efficacy Scale - International
A validated self-report measure of fear of falling that assesses both easy and difficult physical and social activities
Measured: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
Environmental Analysis of Mobility Questionnaire
A validated self-report scale to assess the relationship between characteristics of the physical environment and mobility disability
Measured: Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year
Hospital Anxiety and Depression Scale
A self-report scale to assess anxiety and depression symptom.
Measured: Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year
EQ-5D self-report questionnaire
A standardised measure of health outcome.
Measured: Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year
Vestibular Symptom Scale
A validated self-report scale to assess common vestibular symptoms (i.e. giddiness) and autonomic/somatic anxiety symptoms.
Measured: Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study start1 May 2017 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals, Guy's and St Thomas' NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Marousa Pavlou, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696668
- Sponsor's protocol ID
- KingsCL
- Status last verified
- Mar 2017
- First submitted
- 25 Feb 2016
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Modified FaME vs. a Multisensory Group Balance Programme on Falls Risk, Balance Confidence and Quality of Life in Older Adult Who Fall or Are at Risk of Falling
- ClinicalTrials.gov ID
- NCT02696668
- Acronym / sponsor ID
- KingsCL
- Conditions
- Accidental Falls
- Keywords
- multisensory exercises, group-based balance exercise programme
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals, Guy's and St Thomas' NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study's main aim is to compare the effect of a modified FaME vs. a multisensory balance exercise programme on falls risk, balance confidence and quality of life in older adults who fall or at risk of falling when implemented in a group setting.
Detailed description
Falls in older adults have a major impact on health, morbidity and mortality and have significant cost implications to healthcare providers (Alexander et al., 1992, Tinetti and Williams, 1998, Davis et al., 2010). Government legislation states targeted multifactorial falls rehabilitation programmes should be provided to older adult fallers (Excellence, 2013). The FaME programme, a group based rehabilitation programme is reported effective for improving balance and walking speed, and reducing the number of falls, chance of hospitalization, institutionalization, and death, and fear of falling (Skelton et al., 2005, Yeung et al., 2014). Sensory integration and re-weighting of peripheral sensory information from visual, somatosensory, and vestibular (i.e. inner ear) systems play an important role in maintaining balance (Horak, 2006). However, until recently no studies had incorporated vestibular exercises into falls rehabilitation programmes and therefore, the efficacy of this type of multisensory balance programme in older adult fallers was unknown.
A recent study showed that a programme combining the widely used modified OTAGO falls rehabilitation programme with multisensory balance exercises was feasible in older adult fallers and may have a greater beneficial effect on balance, gait, and falls risk compared to the OTAGO programme in isolation (Liston et al., 2014). However, multisensory rehabilitation targeting sensory integration and re-weighting which is crucial for postural control is not addressed in current guidelines. To develop the best programme for fall prevention, understanding the complexity of postural control and defining a specified exercise programme targeting essential systems is required. The FaME programme includes certain multisensory balance exercises, but these are introduced only in the latter phase of the programme. This study's main aim is to compare the effect of a modified FaME vs. a multisensory balance exercise programme on falls risk, balance confidence and quality of life in older adults who fall or at risk of falling when implemented in a group setting.
Research questions:
Primary research question:
Does exposure to multisensory balance rehabilitation provide better outcome in balance confidence, falls risk and quality of life in older adult who fall or are at risk of falling compared to the modified FaME programme?
Secondary research questions:
- What is the long term effect of a multisensory balance rehabilitation programme vs. the modified FaME on all outcome measure scores and falls rate?
- Is there a relationship between baseline cognitive function, vestibular function and intervention outcome?
- Can vestibular dysfunction be effectively screened for in a community setting?
Study design:
This study will be a single blinded randomised control study to investigate the effect of the multisensory balance rehabilitation programme vs. the modified FaME on falls risk, balance confidence and quality of life in older adults who fall or are at risk of falling. This study will have two arms provided within a community-based setting. This study will compare intervention outcome between participants receiving the modified FaME falls rehabilitation programme and those receiving multisensory balance rehabilitation exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified FaME | Active comparator | Other: modified FaMEParticipants in the modified FaME group will receive a 16 weeks falls rehabilitation programme which will be tailored and progressed according to their abilities and their needs by the physiotherapist / instructor providing the rehabilitation at the hospital. |
| Multisensory | Experimental | Other: MultisensoryParticipants in the multisensory group will receive balance exercises training which will be tailored and progressed to their abilities and needs. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Older adult 65 years old or older who have either experienced a fall or are at risk of falling (Timed Up and Go score >15 seconds) and have been referred by the assessing physiotherapist to a falls rehabilitation group class.
Key exclusion criteria (4 listed)
- Older adults who have:
- Any individual with poor written/spoken English will not be included in the study due to the need to complete multiple questionnaires.
- Individuals with a known history of epilepsy in the last one year or currently experiencing migraine will not be included in this study due to the use of optokinetic stimuli.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified FaMEGroup based exercise classes one hour weekly for 16 weeks. Each exercise class will have 8-10 participants and two instructors. The components of the FaME programme include specific falls management strategies, such as bone loading, gait, dynamic posture, balance, reaction and co-ordination training, functional floor activities to improve coping skills and confidence. | Other | modified FaME |
| MultisensoryGroup based exercise classes one hour weekly for 16 weeks. Each exercise class will have 8-10 participants and two instructors.Participants will receive an initial assessment by the research physiotherapists to determine the most appropriate interventions for each participant. Interventions used will include: 1. Limits of stability training with eyes open / eyes closed 2. Self induced movement strategies with eyes open / eyes closed 3. Gaze stability exercises in sitting / standing / walking 4. Sensory integration 5. Habituation exercises | Other | Multisensory |
Primary outcome
Functional Gait Assessment
Time frame: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
A 10-item test assesses complex gait tasks such as walking with head turns or stepping over an obstacle
8 secondary outcomes
Timed Up and Go test
Time frame: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
Mini Balance Evaluation Systems Test
Time frame: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
Activities-Specific Balance Confidence Scale
Time frame: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
Falls Efficacy Scale - International
Time frame: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks
Environmental Analysis of Mobility Questionnaire
Time frame: Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year
Hospital Anxiety and Depression Scale
Time frame: Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year
EQ-5D self-report questionnaire
Time frame: Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year
Vestibular Symptom Scale
Time frame: Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marousa Pavlou, PhD principal investigator
King's College London
Questions about this trial
What is this clinical trial studying?
A study testing modified FaME and Multisensory in people with Accidental Falls, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marousa Pavlou, PhD (02078486328, marousa.pavlou@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Gait Assessment (time frame: Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.